Rocbrutinib for adults with relapsed or refractory non‑GCB diffuse large B‑cell lymphoma

An Open-Label, Randomized Controlled, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Rocbrutinib Monotherapy Versus Investigator's Choice of Therapy in Patients With Relapsed or Refractory Non-GCB Diffuse Large B-Cell Lymphoma

This test tries rocbritinib alone versus the doctor's choice of bendamustine‑rituximab or lenalidomide‑rituximab in adults whose non‑GCB diffuse large B‑cell lymphoma has relapsed or not responded after at least two prior treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD. (Industry-sponsored)
• Drugs / interventions: Rituximab, Lobertinib, Rocbrutinib
• Locations: 41 sites (Hefei, Anhui and 40 other locations)
• Trial ID: NCT07189065 on ClinicalTrials.gov

What this trial studies

This open‑label, randomized, multicenter Phase II trial compares rocbritinib monotherapy to the investigator's choice of bendamustine plus rituximab (BR) or lenalidomide plus rituximab (R2) in adults with relapsed or refractory non‑GCB DLBCL. Eligible participants are age 18 or older with pathologically confirmed non‑GCB subtype who have failed at least two prior lines of therapy including an anti‑CD20 regimen and have at least one measurable lesion. Patients are randomized to receive oral rocbritinib or the selected comparator regimen and are followed for response, progression, and safety outcomes. Pathology confirmation requires available tumor tissue or slides, and the study is being conducted at multiple centers in China.

Who should consider this trial

Good fit: Adults (≥18 years) with pathologically confirmed non‑GCB DLBCL who have relapsed or are refractory after at least two prior therapies—including an anti‑CD20 antibody—and who have at least one measurable lesion are the intended participants.

Not a fit: Patients with the GCB subtype, those who are newly diagnosed or who have not received at least two prior lines including an anti‑CD20 agent, or those unable to provide tumor tissue or attend the Chinese trial sites are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, rocbritinib could provide an effective new treatment option for adults with relapsed or refractory non‑GCB DLBCL.

How similar studies have performed: Other BTK inhibitors and combinations such as lenalidomide‑rituximab have shown mixed activity in relapsed non‑GCB DLBCL, so this approach builds on prior signals but is not yet proven.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years, any gender.
2. Pathologically confirmed DLBCL (not otherwise specified) according to the revised 2017 WHO classification of lymphoid neoplasms, with non-germinal center B-cell-like (non-GCB) subtype confirmed by Han's algorithm (Appendix 1), based on previous pathological records or confirmed during screening. Must be able to provide sufficient tumor tissue or slides (from previous or screening biopsies) for central laboratory confirmation of pathological diagnosis (if the local pathology report is clear, patients may be enrolled and start treatment without waiting for the central pathology report).
3. Patients who are refractory or have relapsed after at least two prior lines of therapy (at least one line must include an anti-CD20 antibody-containing regimen) (see section 6.3 for definition of refractory or relapsed).
4. At least one measurable lesion (nodal lesion with longest diameter \>1.5 cm, extranodal lesion with longest diameter \>1.0 cm).
5. Not planned for autologous stem cell transplantation (ASCT).
6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.

Exclusion Criteria:

1. Primary central nervous system (CNS) lymphoma or known involvement of lymphoma in the CNS (including patients whose CNS lymphoma is currently in complete remission).
2. DLBCL resulting from histological transformation of an previously diagnosed indolent lymphoma \[such as follicular lymphoma (FL), marginal zone lymphoma, chronic lymphocytic leukemia, etc.\] or pathological findings suggesting concomitant FL (any grade).
3. Diagnosis of other types of large B-cell lymphoma or special types of DLBCL, including but not limited to high-grade B-cell lymphoma, EBV-positive DLBCL, T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal large B-cell lymphoma, etc.
4. Previous exposure to Lobertinib or known allergy to any excipient of Lobertinib (including microcrystalline cellulose, croscarmellose sodium, magnesium stearate, fumaric acid, and gastric-soluble film coating premix); allergy or intolerance to Rituximab or any of its excipients; allergy or intolerance to both Bendamustine and Lenalidomide or any of their excipients.
5. Previous refractoriness to BTK-targeting drugs.
6. Patients who have received autologous stem cell transplantation within 90 days prior to randomization; patients who have received allogeneic stem cell transplantation.

Where this trial is running

Hefei, Anhui and 40 other locations

• Anhui Cancer Hospital (West Branch of Anhui Provincial Hospital) — Hefei, Anhui, China (Not_yet_recruiting)
• Beijing Shijitan Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Tongren Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• National Cancer Center/Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• Affiliated Cancer Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Nanfang Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Meizhou People's Hospital — Meizhou, Guangdong, China (Not_yet_recruiting)
• Affiliated Tumor Hospital of Guangxi Medical University — Nanning, Guangxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Not_yet_recruiting)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Hubei Cancer Hospital — Wuhan, Hubei, China (Not_yet_recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, Hujian, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Not_yet_recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Not_yet_recruiting)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The First Hospital of Jilin University — Jilin, Jilin, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Not_yet_recruiting)
• Liaoning Cancer Hospital — Shenyang, Liaoning, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• Linyi Cancer Hospital — Linyi, Shandong, China (Not_yet_recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)
• Shanxi Province Cancer Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)
• Sichuan Cancer Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Yuankai Shi

Conditions Diffuse Large B-Cell Lymphoma